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Thromb Haemost 2010; 103(06): 1152-1160
DOI: 10.1160/TH09-11-0759
Blood Coagulation, Fibrinolysis and Cellular Haemostasis
Schattauer GmbH

Comorbidities, alone and in combination with D-dimer, as risk factors for recurrence after a first episode of unprovoked venous thromboembolism in the extended follow-up of the PROLONG study

Benilde Cosmi
1   Department of Angiology & Blood Coagulation “Marino Golinelli”, S. Orsola-Malpighi University Hospital, Bologna, Italy
,
Cristina Legnani
1   Department of Angiology & Blood Coagulation “Marino Golinelli”, S. Orsola-Malpighi University Hospital, Bologna, Italy
,
Alberto Tosetto
2   Department of Hematology, S. Bortolo Hospital, Vicenza, Italy
,
Vittorio Pengo
3   Department of Clinical and Experimental Medicine, Division of Clinical Cardiology, University Hospital, Padua, Italy
,
Angelo Ghirarduzzi
4   Department of Internal Medicine I, Angiology, Arcispedale Santa Maria Nuova, Reggio Emilia, Italy
,
Sophie Testa
5   Haemostasis & Thrombosis Center, General Hospital, Cremona, Italy
,
Domenico Prisco
6   Department of Medical and Surgical Critical Care, University of Florence and Centro Trombosi, A.O. U. Careggi , Firenze, Italy
,
Daniela Poli
6   Department of Medical and Surgical Critical Care, University of Florence and Centro Trombosi, A.O. U. Careggi , Firenze, Italy
,
Armando Tripodi
7   Angelo Bianchi Bonomi Hemophilia & Thrombosis Center, Department of Internal Medicine, University & IRCCS Maggiore Hospital, Milan, Italy
,
Gualtiero Palareti
7   Angelo Bianchi Bonomi Hemophilia & Thrombosis Center, Department of Internal Medicine, University & IRCCS Maggiore Hospital, Milan, Italy
,
for the PROLONG Investigators › Author Affiliations Financial support: The study was supported by the Italian Federation of Anticoagulation Clinics (FCSA) and by the Dept. of Angiology & Blood Coagulation of the University Hospital S. Orsola-Malpighi of Bologna (Coordinating Center), Italy. The Instrumentation Laboratory company (Milan) provided the kits for D-dimer measurement (Clearview Simplify-D dimer test).
Further Information

Publication History

Received: 06 November 2009

Accepted after major revision: 12 January 2010

Publication Date:
22 November 2017 (online)

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Summary

The PROLONG randomised clinical trial showed that an abnormal D-dimer at one month after vitamin K antagonist (VKA) suspension for a first episode of unprovoked venous thromboembolism (VTE) is associated with a higher risk of recurrence. However, other patient characteristics, such as comorbidities, in combination with D-dimer could also influence the recurrence risk. It was the objective of this study to assess the predictive value of comorbidities and D-dimer in combination for recurrence after withdrawal of VKA in patients enrolled in the PROLONG study. On the day of VKA suspension, the presence of known (coronary, peripheral,cerebral) vascular disease, chronic inflammatory bowel disease, chronic obstructive pulmonary disease, autoimmune disease, diabetes, arterial hypertension, obesity and dyslipidaemias was registered. D-dimer was measured at 30 ± 10 days afterwards. The primary outcome was recurrent objectively documented VTE. Mean follow-up was 2.55 years. An abnormal D-dimer was observed in 44% (135/309) of patients with comorbidities and in 29% (87/299) of patients without (p=0.0003). An on-treatment analysis was conducted in 483 patients in whom VKAs were not resumed. In patients with a normal D-dimer, recurrences were observed in 14.3% (24/168) of patients with comorbidities and 10.8% (22/203) of subjects without (p=ns). In patients with an abnormal D-dimer, recurrences were observed in 24.6% (16/65) patients with comorbidities and 21.3% (10/47) of patients without (p=ns). Although abnormal D-dimer levels were significantly more frequent in patients with comorbidities, D-dimer was an independent risk factor for recurrence and the presence of comorbidities did not increase the risk of recurrence associated with an abnormal post-anticoagulation D-dimer.

ClinicalTrials.gov number: NCT00264277

Keywords

Venous thromboembolism - risk factors - hypercoagulability - oral anticoagulants - atherosclerosis

* The PROLONG investigators are listed in the Acknowledgements.


 

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